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Stabilized teriparatide solutions

A solution and stabilizer technology, applied in the field of pharmaceutical compositions containing parathyroid hormone, can solve problems such as instability

Inactive Publication Date: 2001-01-24
ELI LILLY & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because it is a protein, it is very unstable compared to traditional small molecular weight drugs, however, parathyroid hormone formulations face challenges not often encountered by the pharmaceutical industry

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 0.1 mg rhPTH(1-34) (SEQ ID NO: 2), 50 mg mannitol, 2.5 mg m-cresol, 0.52 mg acetic acid and 0.12 mg sodium acetate were mixed in 1 ml distilled water.

Embodiment 2

[0045] 0.25 mg rhPTH(1-34) (SEQ ID NO: 2), 45.4 mg mannitol, 3 mg m-cresol, 0.41 mg acetic acid and 0.1 mg sodium acetate were mixed in 1 ml distilled water.

[0046] The formulations of Examples 1 and 2 according to the invention were compared with solutions without stabilizers, 0.9% NaCl, 20 mM acetate and 10 mM acetate as primary stabilizers. Stability was determined by determining the percentage of the amount of rhPTH(1-34) (SEQ ID NO: 2) that remained over time. Assay by HPLC. The results are shown in Tables 1 and 2.

[0047] water

0.9% NaCl

20 mM acetate

10 mM acetic acid

Salt

time day

Retention percentage (%)

start

100

100

100

100

7

74

81

84

80

14

55

58

67

71

20 mM acetate

10 mM acetate

Example 1

Example 2

time day

Retention percentage (%)

start

100 ...

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PUM

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Abstract

A stabilized pharmaceutical composition in the form of a solution for parenteral administration of a parathyroid hormone is described wherein the therapeutically active ingredient is stabilized with a buffer and a polyol. Preferred preparations contain in an aqueous solution human PTH(1-34), mannitol, an acetate or tartrate buffering agent and m-cresol or benzyl alcohol as a preservative.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing parathyroid hormone. More specifically, the present invention relates to stable solution formulations of teriparatide, PTH(1-34). Background of the invention [0002] Parathyroid hormone (PTH) is an 84 amino acid product secreted by the mammalian parathyroid gland that controls serum calcium levels through actions on various tissues including bone. Studies in humans of certain forms of PTH have demonstrated anabolic effects on bone, raising considerable concerns about their use in the treatment of osteoporosis and related bone diseases. [0003] Using the N-terminal 34 amino acids of the bovine and human hormones, which all published reports consider biologically equivalent to the full-length hormone, it has been demonstrated that when parathyroid hormone is administered subcutaneously in a pulsatile manner , parathyroid hormone especially promotes bone growth. A slightly diffe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K9/00A61K9/19A61K38/22A61K38/29A61K47/10A61K47/14A61K47/26
CPCA61K9/0019A61K9/19A61K47/26A61K47/10A61K38/29A61P19/00A61P19/10
Inventor 常亲明亨利·A·哈弗尔
Owner ELI LILLY & CO
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